Hemostatic clip and applicator therefor



May 27, 1969 P. L. LEROY 3,446,212

HEMOSTATIC CLIP AND APPLICA'I'OR THEREFOR Filed July 19, 1965 Sheet of 2 INVENTOR 15 fiierr'e L LeJQ y y 1969 P. LEROY 3,446,212

HEMOSTATIC CLIP AND APPLICATOR THEREFOR Filed July 19, 1965 Sheet 2 of 2 INVENTOR 1 Z-Ze 4367/ 6 BY Mfi ATTORNEYS United States Patent 3,446,212 HEMOSTATIC CLIP AND APPLICATOR THEREFOR Pierre L. Le Roy, Wilmington, Del., assignor to New Research and Development Laboratories, Inc., Wilmington, Del., a corporation of Delaware Filed July 19, 1965, Ser. No. 473,055 Int. Cl. A61b 17/12 US. Cl. 128-325 7 Claims ABSTRACT OF THE DISCLOSURE This invention relates to hemostatic clips and applicators for use in clamping wound flaps to prevent the flow of blood from severed arteries, capillaries, and the like.

One of the most important considerations in an operation is the element of time. With convention-a1 hemostatic clips the operative time is frequently prolonged because of the tedious procedures involved in applying and removing these clips. It is therefore very desirable to minimize the time of clip application and removal. This consideration is even more important during long operations such as the closing of a scalp wound, or in wartime when it is essential to free technical personnel to maximize their efficiency.

An object of this invention is to provide a hemostatic clip which is inexpensive, easily sterilized so that it can possibly be pre-packaged, disposable, adaptable to be made in a variety of dimensions to accommodate a wide range of applications, and can be easily applied and removed by a relatively unskilled worker.

A further object is to provide such a clip which is of the continuous type whereby it may be cut to any desired length.

A still further object is to provide such a clip which is provided with means for visibility, ventilation and drainage of the wound flap.

An additional object is to provide applicators for the above type clips.

In accordance with this invention the hemostatic clip is in the from of an elongated tube having a longitudinal slit so that the tube may be distended from its original shape to permit a wound flap to be inserted into the slit.

In one form of this invention, the clip has a pair of parallel slots extending partially across its tubular body and disposed approximately 90 from the longitudinal slit. The applicator for this clip is advantageously a pliers or reverse acting forceps type device in which its .tip portions are parallel to each other and normally spaced from each other a distance equal to the diameter of the clip. Accordingly, the tips of the applicator may be conveniently inserted in the pair of clip slots and the clip may be distended or spread by manipulating the applicator to spread its tips apart.

In another advantageous form of this invention the clip is of the continuous type which is particularly adapted for disposability, as well as visibility, ventilation and drainage of the wound. In this form of the invention, the longitudinal margin of the tubular body on each side of its longitudinal slit forms a pair of elongated backbones. The remainder of the body is peripherally slotted with parallel spaced ribs spanning the backbones. Accordingly,

the peripheral slots provide the beneficial visibility, ventilation and drainage of the wound.

The applicator for the continuous type clip is in the form of a support rod having a guide member secured at one end thereto. "lhe continuous hemostatic clip is slid on the free or feed end of the guide member toward its discharge end. A pair of grooves at the junction of the discharge end of the guide member and the support rod provides a convenient track for the clip. The distance between the grooves increases toward the dispensing end of the applicator. Accordingly, as the clip is slid off the dispensing end, its longitudinal slot is spread apart. Advantageously, the dispensing end of the applicator may be concave and tapered for receiving the wound flap and registering it with the clip so that the clip is accurately slid on the wound flap. When the desired length is applied to the wound flap, the clip is cut to that length and the remainder of the clip may be used in another location.

The above type clips may advantageously be made of a disposable platic material, and both the clips and the applicators can for example be packaged in a first-aid kit. The clips may also incorporate an X-ray or radiopaque material to easily locate the clips should they be lost within the operative site.

Novel features and advantages of the present invention will become apparent to one skilled in the art from a reading of the following description in conjunction with the accompanying drawings wherein similar reference characters refer to similar parts and in which:

FIG. 1 is a side view in elevation of an applicator in accordance with one embodiment of this invention;

FIG. 2 is a front view of the applicator shown in FIG. 1;

FIGS. 3-4 are a side view and a front view, respectively, of the applicator shown in FIGS. 1-2 in one phase of operation;

FIG. 5 is a front view of the clip shown in FIGS. 3-4;

FIG. 6 is a top view of the clip shown in FIG. 5

FIGS. 7-8 are side views of the clip shown in FIGS. 5-6;

FIG. 9 is a plan view of a first-aid kit incorporating the applicator and clip shown in FIGS. 1-8;

FIG. 10 is a side view of an applicator is accordance with another embodiment of this invention;

FIG. 11 is a front view of the applicator shown in FIG. 10;

FIG. 12 is a cross sectional view taken through FIG. 10 along the line 1212;

FIG. 13 is a plan view of a portion of the applicator shown in FIGS. 10-12;

FIGS. 14-15 are side views of the applicator and its clip in different phases of operation;

FIG. 16 is a cross sectional view taken through FIG. 15 along the line 1616;

FIGS. 17-19 are front, top and side views, respectively, of the clip shown in FIGS. 14-16; and

FIGS. 20-21 are side views of modified clips in accordance with this invention.

FIGS. 1-8 show an applicator and clip in accordance with one embodiment of this invention. As most clearly shown in FIGS. 5-8 clip 10 is tubular in form in that it is in the shape of a hollow body open at both ends. The clip can be constructed from any material possessing the required elastic modulus and physical properties. Nylon tubing, for example, as well as Delrin, Teflon, polyethylene, polypropylene and other suitable polymers and/or plastics are particularly adapted for this invention. Additionally, thin steel tubes or other metal alloys are also suitable. The tubular body can for example be formed into a circular cross section (as shown in the drawings) or may have rectangular, triangular, square,

Patented May 27, 1969 elliptical, or other adaptable cross section having the appropriate physical properties and being clinically acceptable.

Clip 10 may be of any desired length as required by the specific purpose to which it is to be used. Some advantageous lengths for example are one-quarter, one-half and one inch, with the longer length being more suitable for large wound flaps.

As shown in FIGS. 5-8 clip has a longitudinal slit 12 across its entire length so that it can be distended by for example applicator 14 as shown in FIGS. 1-4 to form a C. The slit edges are then applied to the two sides of a wound flap 16 (FIG. 3) or other tissue to prevent the flow of blood from severed arteries or capillaries or the like. At approximately 90 to the longitudinal slit 12 are two parallel and opposed slots 18, 20 which are cut approximately half way along the length of the clip. Slots 18, 20 are of sufficient width to accommodate the tips 22, 24 of applicator l4. Advantageously, the slots 18, 20 are actually somewhat wider than tool tips 22 and 24 to permit easy withdrawal of tool 14 when the clip 10 is in the open C position, because of a pinching effect. In addition to the loading of the clips 10 on the applicator 14, slots 18 and 20 also serve to properly orient clip 10 for attachment to the tissue.

It, of course, is also possible to form some other types of openings in clip 10 to accommodate applicators other than preferred applicator 14. For example the clip can be modified to permit feeding and application by means of a magazine, or an applicator operating on a different principle than applicator 14.

FIGS. 1-4 show the details of applicator 14. This applicator is a pliers type or reverse acting forceps which is pivoted at its central portion 26. As is apparent from the drawings, compression of handles 28, opens applicator 14 to spread the clips (FIGS. 3-4) prior to attachment to the wound or tissue flap 16. Spring 32 is provided between handles 28 and 30 to maintain the applicator in the rest position shown in FIGS. 12. In this position the distance between tips 22 and 24 is substantially equal to the diameter of clip 10 so that the tips can be inserted into slots 18 and 20 and disposed under the unslotted portion of clip 10. The handles 28, 30 are of a length which is selected to provide a proper leverage ratio with respect to the applicator tips 22 and 24, commensurate with the force required to open the resilient hemostatis clips 10. The applicator tips 22 and 24 are of a compound right angle design being in a plane perpendicular to the lane of the remainder of applicator 14 as clearly shown in FIGS. 1-2. This design permits convenient fitting into the clip positioning slots 18 and 20. After placing the clip over the tissue flap 16 as shown in FIG. 3, the applicator is relaxed and returned by spring 30 to its normal position with the clip being firmly secured on flap l6. Applicator 14 is then readily withdrawn from clip 10 by reversing the charging or loading procedure.

Clip 10 has been clinically found to be very effective in a varying range of applications. For example, clip 10 has been successfully applied to wound flaps measuring A; to inch thick. The ease of application is quite notable. Additionally, when necessary, application of tool 14 is conveniently done while clip 10 is still in place bridging the wound, thus permitting adjustment of clip 10 to other positions without undue damage to either the clip or tissue. Moreover use of clip 10 on a wound has ranged for example from 1 to 4 hours and, except for the pressure imprint in the skin, clips 10 have caused no tissue irritation either on removal of the clip or on subsequent postoperative course. Furthermore there have been no allergic response to the patients on whom the clips 10 have been applied.

Clip 10 is more easily and rapidly removed either with applicator 14 or by hand than other previous conventional hemostatic clips. Manual removal is accomplished by simply grasping the greater diameter of clip 10 with the thumb and forefinger, and merely slipping the clip off the wound flap without noticeable damage to the tissue involved. Additionally, no special training is necessary for the scrub nurse, assistant or surgeon in applying or removing clips 10.

Other advantages of clip 10 are that it can be sterilized by either the flash or routine method employing high pressure and high temperature. Clip 10 can also be sufficiently inexpensive to be disposable and thus packaged in presterile units. When desired or necessary, however, clips 10 can be reused. Even if the clips are unduly abused by, for example, being dropped, the clips show no structural fatigue or cracks and maintain their elastic state to a high degree.

Correspondingly, the operative maintenance of applicator 14 is minimal. Applicator 14 may for example be made of a metal which can be autoclaved and handled without any unusual difficulty.

Advantageously, clip 10 may incorporate an X-ray or radiopaque material such as barium sulfate. Accordingly, the clip can be easily located if it should be lost within the operative site. Additionally, a bacteriostatic material may be used for clip 10. Accordingly, items such as iodonated compounds and an alpha or a low energy beta emitter may be added.

As indicated above clip 10 has proven to be exceptionally effective. For example, its ease of application, the lack of tissue irritability, the ease of adjustment, and the rapid removal enable the surgeon to move more quickly on entering the operative field. Clip 10 is particularly effective with scalp and back wounds, and can also be advantageously used on abdominal or long flap wounds as may be necessary in extermity work. Morover, the gentleness with which the blood vessels are compressed and the lack of tissue irritability are especially notable.

The ease of application of clip 10 enables it to be used for example in a first-aid kit 34 as indicated in FIG. 9. Kit 34 thus includes the ordinary first-aid equipment 36 as well as applicator 14 and a set of clips 10. Clips 10 may be all of the same size or, as indicated in FIG. 9, may vary in length. Thus a wounded person could easily selfapply clip 10 without undue difficulty or previous experience on vessels or wounds which are bleeding profusely.

FIGS. 1021 illustrate another clip 40 formed in accordance with this invention. Clip 40 is for example made of a disposable plastic material or materials previously enumerated with respect to clip 10. Clip 40 is of extended or continuous length, being at least 10 inches long, so that it can be cut to the desired size for individual application. Additionally, clip 40 is specifically designed to provide maximum ventilation and drainage of the wound as well as increased visibility thereof.

As indicated most clearly in FIGS. 17-19, clip 40 is of tubular form having a suitable wall thickness and a continuous elongated longitudinal slit 42. Clip 40 may be of any length such as the medium size clip as indicated in FIGS. 18-19 or the extra long clip shown in FIG. 20. The border or margin on each side of slit 42 forms a pair of elongated longitudinal backbones 44 and 46. Additionally, clip 40 includes a plurality of parallel spacer peripheral slots 48 which are separated by ribs 50 spanning backbones 44 and 46. The provision of these perforations or slots 48 not only provides visibility, ventilation, and drainage of the wound flap '52 (FIG. 15), but also permits the delicate adjustment of a balance between the clamping strength and ease of application of clip 40. The thickness of backbones 44 and 46 determines the flexibility of clip 40 and its ability to conform to any Wound configurations. Thus clip 40 can be applied in a bent or curved manner, as well as in a relatively straight line.

Although slots 48 are an exceptionally effective manner of forming perforations in clip 40 it is also possible to form the perforations in other ways, as long as the perforations permit flexibility, adequate clamping force, and visibility of the wound.

One modification of clip 40 is shown in FIG. 21 in which backbones 44 and 46 are serrated along slit 42 to provide more positive traction on the wound flap.

FIGS. -16 illustrate the applicator 60 which is particularly adapted for clips 40. As indicated therein, applicator 60 is made of two parts. One part 62 is a relatively long support rod, one end of which may be conveniently held and used as a handle as shown in FIG. 15. The second member or part is guide rod 64. Guide rod 64 includes a feed end 66 and a discharge end 68. Discharge end '68 is secured to the remote end 70 of support rod 62 to form the dispensing end 76 of applicator 60. Members 62 and 64 are made, for example, in the form of flattened tubular elements as best shown in FIG. 16. Accordingly, a pair of grooves 72 and 74 are formed at the juncture of discharge end 68 and remote end 70. As shown in FIGS. 11 and 13 dispensing end 76 of applicator '60 tapers or widens outwardly. Thus the distance between grooves 72 and 74 also increases.

In use the tubular clip 40 is inserted around feed end 66 of guide member 64 as shown in FIG. 14. Since feed end 66 is spaced from support rod 62, clip 40 can easily be loaded around guide rod 64. Applicator 60 is then brought into the vicinity of wound flap 52. Advantageously, dispensing end 76 of applicator 60 is concave and tapered to act as a registry means for wound flap 52 so that wound flap can be inserted in the concave portion 78 and maintained in position for the applicator of clip 40 as most clearly shown in FIG. 15. Additionally, this registry is facilitated by the tapered end of applicator 60 in which guide member 64 projects slightly beyond support member 62.

After wound flap 52 has been brought into registry in tapered concave portion 78 clip 40 is slid down guide member 64. The end of clip 40 is open or distended by the outwardly tapering dispensing end 76 of applicator 60. Accordingly, clip 40 is simply progressively slid off applicator 60 in an open position onto flap 52.

Applicator 60 which is made of a clinically acceptable material such as steel or other metal or plastic, can easily be held in either hand with the clip 40 being advanced by the thumb of the other hand. When the required length of clip 40 has been applied to wound flap 52, the excess clip can be cut oil by, for example, a scissors. Clip 40 can thereby be easily applied in a simple sweeping fashion. Thus for example for the first time a large area can be clamped by employing two large continuous hemostatic clips 40 by using only two maneuvers, in contrast to the multiple repeated maneuvers which have been required with conventional small clamps. In addition to the above noted advantages of ease of application and removal of clip 40, the clip also renders the operative area free of clutter.

For removal, clip 40 can be fractionally withdrawn from wound flap 52 to allow for surgical closure by interrupted sutures for controlling hemostasis and approximation of tissue planes. This can be done manually, without requiring an instrument, as is ordinarily necessary for conventional clips. Alternatively, the clip 40 can be removed in one sweeping motion, if necessary, rather than fractionally or with the conventional multiple actions.

Obviously, many modifications and variations of the present invention are possible in the light of the above teachings. It is therefore to be understood that within the scope of the appended claims the invention may be practiced otherwise as specifically described.

What is claimed is:

1. A hemostatic clip comprising a body in the form of an elongated tubular element, wound flap engaging means on said body, said wound flap engaging means being an elongated longitudinal slit extending completely across said body whereby said body may be distended from its original shape, a plurality of slots being formed in said body, said slots being a pair of diametrically opposed parallel slots extending from one end of said body to a point approximately halfway across said body, said slots being disposed approximately degrees from said longitudinal slit, and said body being resiliently urged to maintain its original tubular shape whereby the original tubular shape of said body may be distended upon application of force thereto to permit the insertion of a wound flap in said longitudinal slit and said body will return toward its original undistended tubular shape upon cessation of the application of force for firmly engaging the wound flap.

2. A clip as set forth in claim 1 wherein said body is of solid closed construction between said pair of slots.

3. A clip as set forth in claim 2 wherein said body is X-ray opaque.

4. A clip as set forth in claim 2 wherein said body is made of a disposable plastic material.

5. A clip as set forth in claim 2 wherein said body is from 4 inch to 1 inch long.

6. A clip as set forth in claim 2 wherein the opposed edges of said longitudinal slit are serrated to provide a positive traction on the Wound flap.

7. An applicator for applying ashemostatic clip to a wound flap comprising a pair of elongated arms, each of said arms having a handle portion and a tip portion separated by an intermediate portion, pivot means connecting the intermediate portions of said arms, resilient means urging said arms into a rest position with the tip portions of said arms spaced from each other, the tip portions of said arms being parallel to each other in a plane normal to the plane of the remaining portions of said arms, in combination with a hemostatic clip, said clip comprising an elongated tubular body, a longitudinal slit extending completely across said body whereby the original tubular shape of said body may be distorted upon application of force thereto, a pair of opposed parallel slits extending partly across said body approximately 90 from said longitudinal slit, the distance between said slots being approximately equal to the spacing between said applicator tip portions, said slots being at least slightly wider than said tip portions, and said tip portions being inserted into said slots disposed under the unslotted portion of said body whereby actuation of said applicator handle portions causes said longitudinal slit to spread for receiving a wound flap therein.

References Cited UNITED STATES PATENTS 622,610 4/ 1899 Dudley 24259 2,319,316 5/ 1943 Gerendas 24-259 2,536,145 1/1951 Tapke 128-346 2,890,519 6/1959 Storz 29-225 2,973,761 3/1961 Kohl 128-346 3,040,420 6/ 1962 Kulp 29-229 3,056,408 10/1962 Brown 128-325 FOREIGN PATENTS 143,841 10/ 1951 Australia.

164,940 6/ 1921 Great Britain.

464,802 7/1951 Italy.

DALTON L. TRULUCK, Primary Examiner.

U.S. Cl. X.R. 24-255; 29-229; 128-337, 346 

